In a show­down with As­traZeneca, Pfiz­er posts sol­id — and very fa­mil­iar — PhI­II breast can­cer da­ta for ta­la­zoparib

Jen­nifer Lit­ton, MD An­der­son Can­cer Cen­ter

Pfiz­er $PFE came through with pos­i­tive num­bers for its Phase III study of its PARP in­hibitor ta­la­zoparib in ad­vanced breast can­cer — lin­ing up right along­side As­traZeneca’s $AZN lead­ing ri­val Lyn­parza. And the re­sults po­si­tion Pfiz­er to join the PARP line­up as the fourth play­er to toe up to the mar­ket thresh­old — though maybe not in the lead po­si­tion it was promised when the phar­ma gi­ant bought the drug last year.

An­a­lysts have been wait­ing to see how Pfiz­er’s drug, bagged in the $14 bil­lion ac­qui­si­tion of Medi­va­tion, will fare rel­a­tive to the com­pe­ti­tion. It’s a wide­ly frowned on ap­proach by the ex­perts, but mar­ket an­a­lysts love to match up da­ta from two dif­fer­ent stud­ies of the same dis­ease, of­fer­ing caveats on what could be im­por­tant dis­tinc­tions in tri­al de­signs, pa­tient pop­u­la­tions and end­points.

In this case, which begs for a com­par­i­son, the num­bers are close enough to Lyn­parza’s read­out ear­li­er in the year that it will like­ly em­pha­size just how com­pa­ra­ble these ther­a­pies can be, in­clud­ing the com­pe­ti­tion at Tesaro $TSRO (Ze­ju­la) and Clo­vis $CLVS (Rubra­ca).

Pfiz­er’s re­searchers con­clud­ed that there was a 45.8% re­duc­tion in the risk of dis­ease pro­gres­sion in the EM­BRA­CA study, which re­cruit­ed women with HER2-neg­a­tive breast can­cer with germline BR­CA mu­ta­tion. Me­di­an PFS was 8.6 months, com­pared to 5.6 months in the con­trol arm.

The over­all re­sponse rate was 62.6% in the drug arm com­pared with on­ly 27.2% in the con­trol. There were al­so 12 com­plete re­spons­es — no vis­i­ble signs of the dis­ease — for ta­la­zoparib, com­pared to none in con­trol.

“Most no­table for this study was not on­ly the im­prove­ment to date of PFS, but the time to clin­i­cal de­te­ri­o­ra­tion, which was 24.3 months for pa­tients on ta­la­zoparib, ver­sus 6.3 months for those on stan­dard-of-care chemother­a­py,” MD An­der­son’s Jen­nifer Lit­ton not­ed.

Com­pare that to Lyn­parza’s 42% re­duc­tion in the risk of pro­gres­sion, a 7-month ver­sus 4.2-month PFS — or a gap of 2.8 months ver­sus 3 months for ta­la­zoparib — and a 59.9% ta­la­zoparib vs 28.8% chemo ORR.

Both stud­ies com­pared their drug against stan­dard of care chemo.

For­mer Medi­va­tion CEO David Hung sold this drug hard in dri­ving the deal to sell his com­pa­ny to Pfiz­er for $14 bil­lion last year, claim­ing it was clear­ly su­pe­ri­or to every­thing out there. That would be an even hard­er sales job to­day, with the late-stage da­ta on dis­play.

Michael Schmidt didn’t see much day­light be­tween what Pfiz­er and As­traZeneca have on of­fer, and he con­sid­ers that a plus for Clo­vis.

Ta­la­zoparib was pre­vi­ous­ly tout­ed as po­ten­tial “best-in-class” PARP in­hibitor and most po­tent “PARP trap­per”. That said, at least based on the pre­lim­i­nary da­ta dis­closed in PFE’s (MP)press-re­lease this morn­ing, re­sults in breast can­cer look rather sim­i­lar to AZN’s (MP) OLYMPIAD tri­al re­sults of Lyn­parza which were pre­sent­ed ear­li­er this year at AS­CO. We think this bodes well for CLVS. Pos­i­tive EM­BRA­CA da­ta pro­vides ad­dl. val­i­da­tion for PARPs in breast can­cer, how­ev­er po­ten­tial lack of mean­ing­ful clin­i­cal dif­fer­en­ti­a­tion and hence a cred­i­ble com­pet­i­tive threat by ta­la­zoparib should read through pos­i­tive­ly for CLVS.

Tesaro launched the Phase III BRA­VO study to see how their drug per­formed in a sim­i­lar breast can­cer pop­u­la­tion, but not­ed back in March that it couldn’t serve as a reg­is­tra­tion study af­ter pa­tients bowed out, pre­fer­ring to get a mar­ket­ed PARP rather than chemo. The biotech went on to say that it is study­ing its drug in com­bi­na­tion with a check­point ther­a­py in breast can­cer.

Im­age: Shut­ter­stock

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.

Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Marshall Fordyce, Vera CEO

Gene ther­a­py play­er turned kid­ney spe­cial­ist Ve­ra drops a dud in lead­up to Nas­daq, pric­ing well be­low range

Vera Therapeutics took a big risk at the start of the year, pivoting away from its gene editing mission statement to chase a lead kidney drug instead — and they doubled down with an IPO just months later. But investors don’t seem impressed with Vera’s promise, and now the biotech is looking at a far more scaled-back offering.

On Friday, Vera priced its 4.35-million-share IPO at $11 per share, well below its targeted range of $14 to $16 and good for $47.58 million in proceeds. The biotech will start trading Monday under the ticker $VERA.

Darren Ji, Elpiscience CEO (Lilly Asia Ventures)

Kept an ocean away from its sci­en­tif­ic ad­vi­sors, Shang­hai's Elpi­science keeps up the clin­i­cal progress, re­fu­els for its I/O pipeline

When Elpiscience pooled $100 million for its Series B in late 2019, CEO Darren Ji promised to move what he described as one of the broadest immuno-oncology pipelines swiftly through the clinic in both the US and China.

Then a pandemic got in the way — but not by much. The Shanghai-based biotech managed to keep testing its 4-1BB/PD-L1 drug, get an OX40 agonist cleared for clinical trials (nabbing a collaboration with Junshi in the process), while in-licensing a Phase I bispecific from California’s TRIGR Therapeutics.

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